Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine in Uterine Cervical Cancer (GEMCOL)

July 23, 2012 updated by: Centre Oscar Lambret

Stage IB2 to IVA Uterine Cervical Cancer: Phase 2 Study to Assess a New Therapeutic Sequence Associating a Radiochemotherapy Followed by Adjuvant Chemotherapy Based on Gemcitabine

The scope of the trial is to assess the efficacy of the association gemcitabine-cisplatin + radiotherapy followed by an adjuvant chemotherapy

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dechy, France, 59187
        • Centre Leonard de Vinci
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18 and 70 years old
  • Cervical uterine cancer (epidermoid or adenocarcinoma, stage:from IB> or = 4 cm to IV, according to FIGO classification) histologically proven
  • Measurable lesions,clinically and by MRI assessed
  • PS-WHO < or = 2 ou Karnofsky Index >70 per cent
  • Life expectancy > 3 months
  • Hematologic function: leukocytes < or = 3 G/l, polynuclear neutrophil leukocytes > or = 1.5 G/l, platelets > or = 100 G/l, hemoglobin > or = 10 g/dl
  • Hepatic function: ASAT and ALAT < 2.5 ULN
  • Renal function: creatininemia < 1.5 ULN, clearance > 60 ml/min
  • No prior chemotherapy or radiotherapy
  • Contraception
  • Written informed consent signed

Exclusion Criteria:

  • Stage IB < 4 cm or IVB
  • Other histology than epidermoid or adenocarcinoma
  • Distant metastases, including sus-clavicular adenopathy
  • Contraindication to MRI
  • Pregnant or lactating woman
  • Auto-immune disease
  • Peripheric neuropathy, autograft or homograft, psychiatric disease
  • Prior cancer (except cutaneous basocellular carcinoma and uterine cervical carcinoma in situ)
  • Active infection
  • Other clinical trial with an experimental drug
  • Known positive serology (HIV, HbC, HbS)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient with cervix cancer
will receive gemcitabine + cisplatin + radiotherapy
Drug: Gemcitabine
125 mg/m² at day 1, 8, 15, 21 and 28, 2 hours before radiotherapy.
Procedure: Radiotherapy

45Gy (5 x 1,8Gy/week) on pelvic area +/- boost (10 to 15Gy)

+/- 45Gy (5 x 1,8Gy/week)on lumbo-aortic area

Drug: Cisplatin
40 mg/m² at day 1, 8, 15, 21 and J28 before Gemcitabine and with a hyperhydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: 3 years after the end of study treament
3 years after the end of study treament

Secondary Outcome Measures

Outcome Measure
Time Frame
Global survival
Time Frame: 5 years after the end of study treatment
5 years after the end of study treatment
safety
Time Frame: untill 5 years after study treatment
untill 5 years after study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Investigators

  • Principal Investigator: BELKACEMI Yazid, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEMCOL 0401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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